Saccadometry in Primary Headache Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395264
Recruitment Status : Terminated (Lack of available clinical time to complete)
First Posted : July 15, 2011
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):
Tim Young, University College London Hospitals

Brief Summary:

Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and impact, migraine pathophysiology is poorly understood. A wider understanding of the functional changes in this disorder would be beneficial to both diagnosis and treatment.

Saccades are the rapid eye movements we make when moving the eyes to a new object in our visual field. Reaction time studies have been used to investigate Huntington's disease and Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements). Even at rest we make approximately three saccades per second, so a lot of data can quickly be gathered with non-invasive testing. We hope to understand more of the underlying mechanisms of migraine by studying reaction time in migraine patients.

Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed significantly different saccadic patterns to non-migraineurs.

This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study in a group of migraineurs, and secondly to explore the specificity of these findings in migraine by also studying patients with another primary headache syndrome, namely cluster headache.

Migraine is known to be a dynamic disorder, with previous studies showing longitudinal changes in the migraine brain. To explore this further we hope to record longitudinally (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal changes in saccadic reaction time. Because of the portability of the equipment this could be done in the subjects own home if they preferred.

Condition or disease
Migraine Cluster Headache Control Menstrual Migraine

Detailed Description:
As above

Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Saccadometry in Primary Headache Syndromes
Study Start Date : August 2011
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Episodic Migraine.
menstrual migraine
Cluster Headache patients
control (non-headache group)

Primary Outcome Measures :
  1. To see if Saccadometry results differ between controls and migraine subjects [ Time Frame: By May 2019 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
From hospital Headache clinics (secondary and tertiary)

Inclusion Criteria:

  1. Male or female and aged between 18 and 60 years in good general health apart from suffering from headaches (test group).
  2. Migraine and cluster headache will be diagnosed according to ICHD-II diagnostic criteria (6).
  3. Migraineurs must suffer at least two migraine attacks per year and no more than 5 attacks per month.

Exclusion Criteria:

  1. Any other neurological disorder such as stroke, multiple sclerosis, epilepsy, concussion within the past year, psychiatric disorders, visual disorders.
  2. Use of migraine prophylactic medication in the last month or acute migraine therapy in the 3 days prior to testing.
  3. Patients on any medication to treat depression in their case
  4. Headache during testing or within 3 days before and after testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01395264

United Kingdom
Neurology Department, Whittington Hospital
London, United Kingdom, N19 5NF
The National Hospital for Neurology and Neurosurgery, London WC1N 3BG, and The John Radcliffe hospital, Oxford, The Whittington Hospital N19 5NF London
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
Tim Young

Responsible Party: Tim Young, Doctor, University College London Hospitals Identifier: NCT01395264     History of Changes
Other Study ID Numbers: 10/0366
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Migraine Disorders
Cluster Headache
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias